Warning on statins: FDA more open about risks

Not long ago, statins were jokingly promoted by some doctors with a “put them in the drinking water” argument. Physicians and drug company experts suggested that the ubiquitous cholesterol-lowering drugs -- including Lipitor, Mevacor, Crestor and Zocor -- should be sold over the counter like cold medications, or offered to everyone above a certain age. The medications appeared so beneficial to health and seemed so free of side effects.

But on Tuesday, the Food and Drug Administration issued a new health alert requiring the drugs carry labels warning about confusion and memory loss, elevated blood sugar leading to Type 2 diabetes, and muscle weakness.

“These warnings should put an end to the all the silliness about giving the drugs to everyone,” says Dr. Garret FitzGerald, chairman of pharmacology at the University of Pennsylvania.

There is no question that statins -- the most profitable and among the most prescribed drugs ever -- have saved or prolonged millions of lives and will continue to do so. Most people at elevated risk for heart disease should be taking statins. The big issue now will center on determining whose risk is low to moderate and may not need medication.

The not-so-well-kept secret is that a daily dose of statin allows millions to eat whatever fatty food they like without worrying how it affects their cholesterol levels. That’s a tempting proposition. At the same time, drug companies find nothing more appealing than a pill that healthy people take daily for the rest of their lives. These two motivations combine to get million on statins who may not need them -- not much of a problem if there are no risks. But now we have evidence there is.

The FDA approved the first statin, Merck’s lovastatin, in 1987. Other companies produced their own versions over the last two decades as evidence of the drugs’ effectiveness continued to accumulate, adding to their popularity. But, early on, plenty of side effects warnings popped up.

Every time NBC News reported on statins I would receive many communications from viewers who had suffered the muscle-weakening condition, known as rhabdomyolysis, after taking the medication. When they stopped the drug, their muscles usually returned to normal. Doctors who frequently prescribe statins report that a certain percentage -- the best guess is about ½ to 1 percent -- suffer the muscle problems. That’s a rare occurrence as side effects go, but when many millions are taking the drugs, the numbers add up.

As for elevated blood sugar and memory problems, both conditions have been reported for years, but it is harder to guess how widespread the complications are. In fact, last month, a survey of 150,000 participants in the Women’s Health Initiative -- the government’s gigantic study that ended most hormone replacement -- found that older women taking statins were 48 percent more likely to develop diabetes. (The researchers tried to control for obesity and other risk factors.)

Because most people who take statins tend to be older, they’re already more likely to develop diabetes or memory problems. The only test to accurately measure the risk from statins would be a long, controlled trial of thousands of people at low risk for heart disease where half get the drug and half get a placebo. No drug company will pay for it.

Astra Zeneca’s Crestor remains the only statin still under patent protection, and it would be foolish for that company to go looking for harmful side effects. The government’s resources for big expensive studies grow ever more scarce. We may never know the true danger, but at least now the drugs have labels telling patients and doctors to be aware of them

Why did the FDA chose to label the drugs now when the danger signs have been around for years? There is no official answer, but the officials in charge of the FDA now have shown far more willingness to be honest about public health risks than many of their recent predecessors.

As for whether you or a loved one should be taking a statin drug: This is certainly not an automatic decision, but definitely a subject for a discussion with your physician. Because of the FDA’s labeling actions that decision should now be far better informed.